MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.0/30; CORONARY DRUG-ELUTING STENT

Model Number 364514

Device Problems Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The returned instrument was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation of the returned product revealed that both balloon shoulders are slightly opened.The stent was returned separately and is severely deformed over its entire length.Microscopic inspection of the guidewire exit port revealed that both the guidewire lumen and the inflation lumen are sliced open longitudinally.During functional testing water was found leaking from the guidewire exit port.The balloon could not be inflated.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.The damage at the guidewire exit port was most likely caused during the preparations for the intervention or during the insertion phase.

Event Description

An orsiro drug-eluting stent was selected for treatment of a lesion (85 percent stenosis degree) in a diagonal branch.After placing the stent in the lesion, the balloon could not be inflated properly and a leakage was detected.Upon attempt of removal the stent dislodged.An attempt to retrieve the stent with a snare was unsuccessful.An injury of the vessel has occurred and needed to be treated.The stent was removed by surgery.Date of event unknown.

• Brand Name: ORSIRO 3.0/30
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 10115859
• MDR Text Key: 193710542
• Report Number: 1028232-2020-02275
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P170030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2021
• Device Model Number: 364514
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03192580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention